Panoramic Loupes - Various

No FDA recalls found in the data synced 12 Oct 2026.

510(k) Number

K841293 ↗

FDA Product Code

HLT

Device Class

Class II

Regulation

21 CFR Part 886.1640

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Henson Cfa 3000 Central Visual Field Screener

  Class I

  FDA 510(k) K891610 Active Cleared 5 Jun 1989

• Keeler Tearscope-Plus

  Class II

  FDA 510(k) K973064 Active Cleared 7 Apr 1998

• Vickers Ergomatic Micros Instr-Long R or L Handed

  Class I

  FDA 510(k) K853180 Active Cleared 28 Oct 1985

• Henson - Hamblin Cfs 2000 Central Field Screen

  Class I

  FDA 510(k) K864467 Active Cleared 15 Dec 1986

• Spectacle Indirect Ophthalmoscope

  Class II

  FDA 510(k) K841292 Active Cleared 9 May 1984

• Vista Finoff Transilluminator (Ac-Powered)

  Class II

  FDA 510(k) K893170 Active Cleared 5 Jun 1989

See all devices from Keeler Instruments, Inc. →